Caring for BRAIN pioneers: Understanding and enhancing family and researcher support in neural device trials

项目摘要 大脑先驱是那些作为人类第一人或早期参与者而承担重大风险的人 神经技术是为了帮助进一步发展科学而研究的。他们愿意尝试侵入性和非侵入性 医疗必需的设备，它们投入了大量的时间和精力，以及它们与 研究团队通常在3-5年的密集实验中建立，这使他们成为相对独特的研究人员 参与者。他们的健康对于神经技术领域的持续发展是不可或缺的，但 相对较少的神经伦理关注集中在支持的结构上，来自研究人员和来自 家庭成员，使大脑先驱能够成功参与神经设备试验。在这项研究中， 我们：1)利用嵌入的伦理学家来观察参与者之间的长期、可植入的互动 神经设备试验，他们的家庭伙伴，以及研究团队，以确定提供的护理和支持模式 在实验环境中；2)使用定性访谈来探索参与者、家庭成员和 研究人员阐明了家庭和研究人员关怀和支持的作用、好处和局限性， 在试验期间和之后；以及3)制定最佳做法建议，以实现更具包容性的支持 结构在研究设计和实践中的应用。

Project abstract BRAIN pioneers are people who take on significant risk as participants in first-in-human or early neurotechnology studies for the sake of helping to further science. Their willingness to try invasive and non- medically necessary devices, their investments of significant time and energy, and their close relationships with study teams, typically built over 3-5 years of intensive experiments, make them relatively unique as research participants. Their well-being is integral to the continued development of the field of neural technology, yet relatively little neuroethical attention has been focused on the structures of support, from researchers and from family members, that enable BRAIN pioneers to successfully participate in neural device trials. In this study, we: 1) Utilize an embedded ethicist to observe interactions between participants in long-term, implantable neural device trials, their family partners, and the research team to identify modes of care and support provided in the experimental setting; 2) Use qualitative interviewing to explore how participants, family members and researchers articulate the role, benefits, and limitations of family and researcher care and support before, during, and after a trial; and 3) Develop recommendations for best practices for a more inclusive support structure in research design and practice.